FDA product code FEF: Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
FEF is the FDA product code for tube, single lumen, with mercury wt balloon for intestinal intubation and / or decompression. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FEF. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FEF clearance
Top FEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 1 | 1988-03-11 |
Most recent FEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880253 | Orthopedic Systems, Inc. | BLAKEMORE RETAINER | 1988-03-11 | 51 |
Recalls for FEF devices
openFDA lists no recalls for product code FEF.
Frequently asked questions
What is FDA product code FEF?
FEF is the FDA product code for tube, single lumen, with mercury wt balloon for intestinal intubation and / or decompression. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FEF?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEF?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most FEF clearances?
Orthopedic Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEF
- Run a recall and safety report across every FEF manufacturer
- Watch product code FEF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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